Monday 9 October 2017

Artemether Tablets (Assay) (By HPLC) | Finished Product | Test Procedure | Method of analysis (MOA) |


















By HPLC

Column: C18 octadecylsiiyl silica gel (25 cm x 4.6 mm)

Wavelength: 215 nm

Injection volume: 20 µl

Flow rate: 1.0 ml/min

Solution preparation:
Mobile phase: Prepare a mixture of 700 volumes of Acetonitrile, 300 volume of water and 5 volume of glacial acetic acid, filter and degas.

Diluent: Prepare a mixture of 50 volumes of acetonitrile and 50 volumes of water.

Blank solution: Diluent

Standard solution: Weigh accurately about 80.0 mg of Artemether working standard and transfer to a 100 ml volumetric flask, add 50 ml of diluent, sonicate to dissolve and dilute to volume with diluent.

Further transfer 5.0ml of above solution to 50 ml volumetric flask and dilute to volume with diluent. (0.80 mg/ml)

Test solution: Transfer an amount of finely tablet powdered tablets (powder not less than 20 tablets), equivalent to 80.0 mg of Artemether to a 100 ml volumetric flask. Add 50 ml of diluent, sonicate for 10 minutes with intermittent shaking, cool it and dilute upto the mark with diluent, mix and filter the solution through whatman filtter paper.

Further transfer 5.0ml of above solution to 50 ml volumetric flask and dilute to volume with diluent. (0.80 mg/ml)

Procedure: Separately inject blank solution one time, standard solution six times and test solution two times into the chromatograph. Record the peak responses and evaluate statistically.
% RSD for standard solution is not more than 2.0%.


Calculation:

Content of Artemether in mg/tablet =